Commissioning, Qualification, and Validation (CQV) for life sciences such as the pharmaceutical industry can be challenging and commonly contribute to late project completion due to the CQV process alone. In a typical project mechanical commissioning is often a significant source of delay and adding the steps necessary to meet Good Manufacturing Process (cGMP) requirements increases the risk of delay. This can be solved with early involvement by appropriate parties to help streamline the construction process to support the desire for expedited time-to-market. Scheduling is central to this effort and it is vital that all the final steps necessary to gain final approval and turn over a pharma project to operations are efficiently implemented in the project schedule from the baseline preparation. This webinar will demonstrate an effective and efficient approach to scheduling of the CQV process that supports minimal time-to-market.
Learning Objectives:
- Develop an understanding of the scope of Commissioning
- Recognize the additional scope with Qualification and Validation
- Understand how best to plan and schedule the full process, including
- Schedule Levels at different Stage Gates
- Involvement (and level of) per Stage Gate
- Roles of Master Schedule (Owner) and Commissioning agent schedules or EPCM Schedule
About the speakers:
Chris Carson, CCM - Director of Program & Project Controls and Vice President, Arcadis U.S., Inc.
Leo Carson-Penalosa - Project Controls, Merck
Continuing Education:
CMCI Recertification Points: 1
Professional Development Hours (PDH): 1